Dr Shezad Malik Law Firm has offices based in Fort Worth and Dallas and represents people who have suffered catastrophic and serious personal injuries including wrongful death, caused by the negligence or recklessness of others. We specialize in Personal Injury trial litigation and focus our energy and efforts on those we represent.

Articles Posted in Toxic Injury

As a Texas medical doctor and Dallas Hydraulic Fracking Attorney I am providing this information and commentary.


The EPA is prohibited from regulating hydraulic fracturing under the Safe Drinking Water Act. On July 28, 2011, the EPA proposed federal regulations to reduce smog-forming pollutants released by the hydraulic fracturing approach to gas drilling.

According to the EPA, If approved, the rules would amount to the first national standards for fracking of any kind. The agency sets guidelines when companies inject fluids underground, but in 2005 Congress prohibited the EPA from doing so for fracking. Regulation has been left to the states, some of which compel companies to report what chemicals they use and have imposed tougher well-design standards.

The new EPA proposal would limit emissions released during the stages of natural gas production and development, and targets the volatile organic compounds released in large quantities when wells are fracked. According to the EPA, drillers would have to use equipment that captures these gases. According to environmental experts, the proposed rules represent a step by federal regulators amid a growing controversy over fracking’s safety.

The American Petroleum Institute, the country’s main oil and gas lobbying group, has requested that the EPA delay finalizing the rules for at least six months beyond the current Feb. 2012 deadline.

The Marcellus Shale Coalition, a group representing gas drillers in the Northeast, issued a statement criticizing the proposed regulations, saying they would “undercut” gas production.

The EPA proposal is the result of a successful 2009 lawsuit brought against the agency by WildEarth Guardians and another advocacy group alleging that the agency had not updated air-quality rules as required. The EPA is supposed to review such rules at least every eight years, but in some cases had not done so for 10 years or more.

According to Jeremy Nichols, the climate and energy program director for WildEarth Guardians, hydraulic fracturing is a major source of emissions because when fluids used to frack a well return to the surface, they carry gases that can be vented into the air. In fracking’s case the soupy return contains methane, volatile organic compounds and toxic chemicals such as benzene, which generally spray into the environment. In some gas drilling areas, where emissions from drilling are particularly high, they no longer meet federal air quality standards.

The EPA proposal also calls for reducing emissions of toxic chemicals, such as cancer-causing benzene, produced by processing, transmitting and storing natural gas. Some environmentalist experts were disappointed that the proposed rules do not target methane, a potent greenhouse gas that is also the primary ingredient of natural gas. The oil and gas sector accounts for nearly 40 percent of all methane emissions nationwide, according to the EPA.

Click here. Drilling Regulatory Staffing in Your State. Search for how many wells have been drilled and how many gas regulators are in your state.

Click here. Graphics: What is Hydraulic Fracturing? Anatomy of a Gas Well

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As a Texas medical doctor and Dallas DePuy Pinnacle hip replacement Attorney I am providing this information and commentary.


Johnson and Johnson Pinnacle hip trials

Johnson and Johnson Pinnacle hip trials. DePuy is under fire over its Pinnacle/Ultamet line of metal hip devices causing metal poisoning and premature failure according to lawsuits.

DePuy Orthopaedics ASR hip replacement devices have resulted in a tsunami of lawsuits against DePuy’s parent company, Johnson & Johnson. Could the DePuy Pinnacle hip replacement result in a similar wave of litigation against the device maker?
According to sources, Johnson & Johnson faces approximately 1,000 lawsuits related to its metal-on-metal hip replacement devices. Both the ASR and the Pinnacle are metal-on-metal devices. The ASR devices were recalled following reports of high failure rates in the devices. The Pinnacle has not been recalled.

DePuy claims that a report from Britain that showed a high failure rate was the first sign that there was a problem with the metal-on-metal hip device. When DePuy knew about the high failure rate of its ASR devices will be a key issue in litigation concerning the ASR. Some lawsuits allege DePuy knew in 2007, approximately two years before the device was recalled, about the high failure rate associated with the ASR.

In addition to failure of the hip device—which can result in revision surgery to replace the faulty hip device—some patients say they have developed toxic levels of cobalt and chromium in their bloodstream, a side effect of metal debris coming loose from the hip replacement device. This medical condition is called metallosis.

Some lawsuits have been filed against DePuy concerning the Pinnacle, although those lawsuits reportedly number in the dozens, not in the thousands. According to reports, similar defects have been reported in the Pinnacle as in the ASR devices. DePuy defends the Pinnacle as a safe and effective device.

According to experts, Johnson & Johnson could face up to $1 billion in liability and costs linked to the DePuy ASR lawsuits. Many lawsuits filed against Johnson & Johnson have been consolidated in federal court. Whether or not Johnson & Johnson and DePuy Orthopaedics will face a wave of litigation related to the Pinnacle remains to be seen.

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As a Dallas Denture Cream Side Effect Attorney, I am providing this Poligrip Zinc side effect litigation update.


GlaxoSmithKline may have paid out more than $120 million in Poligrip denture cream settlements to resolve claims brought by consumers who suffered permanent nerve damage due to zinc in the adhesive products. According to sources, the manufacturer has settled more than 100 denture cream lawsuits at an average cost of just over $1 million per case.

Glaxo agreed to remove zinc from its line of denture-cream products after researchers linked some neurological problems, including nerve damage, to use of zinc-laden denture adhesives. The company’s Super Poligrip Original, Ultra Fresh and Extra Care products all contained zinc, which improves adhesive power. Glaxo and Procter & Gamble Co. (PG), the Cincinnati-based maker of the competing Fixodent denture cream, had lawsuits filed against them consolidated before a federal judge in Florida in 2005.

Product liability lawyers allege that the drugmakers knew for years that their products contained harmful levels of zinc and failed to warn customers. Zinc poisoning can deplete the body of copper, which can lead to nerve damage, resulting in weakness in the arms and legs, balance problems and memory loss.

A flood of law suits followed a 2008 University of Texas Southwestern Medical Center in Dallas medical study of patients suffering from neurological problems. The study linked the cause to denture-cream use. According to the complaints, high amounts of zinc in the denture adhesive can enter the body through use of Super Poligrip, leading to permanent neurological problems like neuropathy, numbness, tingling, pain, weakness, loss of sensation, loss of balance, paralysis and difficulty breathing.

The first Fixodent nerve damage trial is scheduled to begin on June 20. In that case, lawyers for Florida resident Marianne Chapman allege Procter & Gamble defectively designed Fixodent by including zinc in its formulation. The consolidated case is In Re Denture Cream Products Liability Litigation, 09-02051, U.S. District Court, Southern District of Florida (Miami.)

There have been no reports of Fixodent denture cream settlements. Proctor and Gamble argues that its products contained less zinc than those of Glaxo and that it does not believe Fixodent can cause neurological damage.

All federal lawsuits over zinc poisoning from denture cream have been centralized in the U.S. District Court for the Southern District of Florida for pretrial litigation. Individual complaints filed by dozens of people throughout the United States have been consolidated to avoid duplicative discovery, inconsistent pretrial rulings from different judges and to serve the convenience of the court, the parties and the witnesses.

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As a Multaq Dangerous Drug attorney and Texas medical doctor, I am providing this information on a drug company sponsored trial of its drug Multaq, which was halted because of increased cardiovascular side effects and injuries.


Sanofi, maker of dronedarone (Multaq), has stopped its phase 3b trial of its antiarrhythmic drug due to an increase in cardiovascular events seen in patients with permanent atrial fibrillation – an unapproved indication for the antiarrhythmic drug. The PALLAS trial was testing the drug in patients with permanent atrial fibrillation (AF) and at least one other cardiovascular disease risk factor; at present, dronedarone is approved in patients with nonpermanent AF.

According to the primary medical investigator, “. . . there was a significant increase in major cardiovascular events, and in our study that was defined as a composite of stroke, MI, systemic embolism, or cardiovascular death. . . . These were pretty important events.”

Multaq, is approved for patients with the non-permanent kind of atrial fibrillation. The trial, known as the PALLAS study, was testing Multaq’s usefulness in patients with permanent atrial fibrillation (more than 6 months of the abnormal rhythms).

Dronedarone has faced a range of criticisms since its approval in the US in July 2009, including questions about its safety/efficacy tradeoff and the design and execution of the ATHENA study. Just last week, newspapers in France reported that French health authorities had concluded that the efficacy of dronedarone was “insufficient”—an opinion that could lead to the drug being dropped from the country’s drug reimbursement formulary.

Dronedarone, sold by sanofi-aventis, is currently approved to treat atrial flutter and paroxysmal or persistent – but not permanent atrial fibrillation.

The phase 3b trial, called PALLAS, had enrolled 3,148 patients with permanent atrial fibrillation, with 70% showing symptoms for more than two years, according to a company statement. Sanofi did not specify the cardiovascular events seen in the dronedarone-treated patients, or the magnitude of the increase.

In January, sanofi-aventis and the FDA warned that reports of acute liver injury associated with the drug had been received. The statement noted that patients with permanent atrial fibrillation and “vascular risk factors” are at high risk for cardiovascular events.

An earlier trial of dronedarone in patients with relatively severe heart failure, called ANDROMEDA, was halted early when mortality in patients receiving the drug was found to be twice that seen in the control group.

Sanofi-aventis has alerted healthcare professionals to several reports of liver function test abnormalities and hepatocellular injury in patients treated with its atrial fibrillation drug dronedarone (Multaq). The Dear Healthcare Provider letter included two post-marketing case reports of acute liver failure that required transplantation, occurring at four-and-a-half and six months after the start of dronedarone therapy. The patients – both female and about 70 years old – had had normal hepatic serum enzymes before starting the drug.

In the letter, sanofi-aventis instructed healthcare professionals to tell patients to immediately report any symptoms suggestive of hepatic injury. According to the FDA, these include anorexia, nausea, vomiting, fever, malaise, fatigue, right upper quadrant pain, jaundice, dark urine, or itching.

Periodic liver enzyme tests, especially in the first six months of treatment, should also be considered, according to the FDA, although it is unknown whether such a strategy will prevent the development of liver injury.

Dronedarone’s prescribing information will be updated to include the guidance from the Dear Physician letter, and will be distributed after the FDA approves it. The agency confirmed that a warning about potential liver injury will be added to the drug’s label.

According to the FDA, from the drug’s approval in July 2009 through October 2010, about 492,000 prescriptions for dronedarone were dispensed and about 117,000 patients filled prescriptions at U.S. pharmacies.

The drug was approved with a Risk Evaluation and Mitigation Strategy to prevent use in patients with severe heart failure or in those with less severe heart failure who were recently hospitalized for the condition. Such patients had a doubling in the risk of death in a placebo-controlled study.

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As a Texas Chantix side effect and Product Liability Attorney and Texas medical attorney, I am providing this update.

New medical research suggests that Chantix side effects increases the risk of heart attacks, strokes and other cardiovascular events.


Pfizer’s smoking cessation drug Chantix raises the risk of suffering a cardiac event by 72%, according to a study published in the Canadian Medical Association Journal.

Researchers found that those who took Chantix were substantially more likely to suffer heart problems than those who took a placebo, and two of the co-authors suggested that the findings were strong enough that the FDA should consider a Chantix recall due to the risk of heart attack and stroke.

The study comes just three weeks after the FDA issued a drug safety communication about the risk of heart problems from Chantix, warning that the smoking cessation drug might increase the risk of certain cardiovascular events, including the risk of heart attack, among individuals who had cardiovascular disease. The U.S. Food and Drug Administration (FDA) is notifying the public that the smoking cessation aid Chantix (varenicline) may be associated with a small, increased risk of certain cardiovascular adverse events in patients who have cardiovascular disease. This safety information will be added to the Warnings and Precautions section of the Chantix physician labeling. The patient Medication Guide will also be revised to inform patients about this possible risk.

The warning risk of a heart attack or stroke from Chantix is just the latest of serious side effects associated with the drug. Warnings about the risk of life-threatening psychological side effects of Chantix, which increases the risk of suicide, was added to a black box on the medications label two years ago.

Chantix (varenicline) was approved in the United States by the FDA in 2006 as a prescription medication to help people quit smoking. The prescription medication designed to help people stop smoking already holds the title of being the drug associated with the most FDA adverse event reports of any prescription medication in the United States.

A number of Chantix lawsuits have been filed in courts throughout the United States on behalf of individuals who have died or suffered serious injuries as a result of a suicide or unusual behavior allegedly caused by Chantix.

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As a DePuy ASR and Pinnacle Metal on Metal Hips attorney, I am providing this update. It is in our nature to want the latest and greatest — whether it is a faster car, a smarter computer or a smaller cell phone, and this applies equally to medicine, where we want the newest and presumably safer drugs and medical devices.


But medical innovation can become a trap for the unwary; we are now seeing this playing out with deadly consequences for thousands of patients who are using the 4th generation birth control pills Yaz and Yasmin over the safer 3rd generation older contraceptive pills and those folks who now are the recipients of metal on metal artificial hips.

The metal-on-metal hips, were regarded by hip manufacturers and surgeons as a technological break through over previous designs that used both metal and plastic. Now the FDA (who had been asleep at the wheel) and medical researchers are panicking to determine how many implant recipients have been injured by the devices.

The Food and Drug Administration recently ordered manufacturers of all metal hips to undertake emergency studies of patients. The rush to implant the latest and greatest, and patients’ demand shows how innovation’s siren call led a product promoted as a breakthrough without convincing evidence that it was better or even as good as existing options.

In 2010, DePuy, the orthopedics division of Johnson & Johnson, recalled one of its all-metal hips, the ASR, which was failing at a high rate. Furthermore, another DePuy product, the Pinnacle (which has not yet been recalled) is now under scrutiny for excessive failures. Another manufacturer, Zimmer Holdings, also briefly halted sales of one of its metal models, the Durom. DePuy, Zimmer and other companies continue to deny that there are any problems with their products.

THE modern artificial hip, which was developed in the 1960s, uses a simple design. A metal “ball” made of cobalt and chromium replaces the top of the thigh bone, while a “cup,” typically made of plastic, serves as an artificial hip socket. By the 1990s, the devices were considered highly effective, with studies then finding that implants still worked a decade after surgery in 95 percent of patients.

By 2008, metal on metal hips were used in one out of every three hip replacements, of approximately 250,000 hips implanted annually in the United States. By using a metal cup, which is thinner than a plastic one, a surgeon could implant a bigger ball component, which was assumed to be less likely to dislocate than a smaller one. But recent research, demonstrates that such oversized components may be the reason the devices shed metallic debris.

As the number of affected patients nationwide increased, it became apparent that the devices had not been properly tested. Under F.D.A. regulatory rules, most all-metal hips do not have to undergo clinical trials before sale. They are tested in labs on machines that simulate millions of steps to study the forces exerted by years of motion. According to testing experts, all-metal devices proved worse than metal-and-plastic ones to small variations in how they were implanted, with components sometimes striking together and generating debris.

The devices, as a group, are twice as likely as metal-and-plastic ones to require early replacement, according to data from Australia’s orthopedic registry, one of the most comprehensive databases on implants. Most importantly, damage from debris generated by metal implants in some patients, has caused crippling tissue and muscle damage, and has produced neurological problems, a condition known as metallosis.

It is estimated, about 500,000 patients in the United States may have gotten an all-metal hip, and thousands will have painful early-replacement procedures. The lawsuits against DePuy and other makers of all-metal hips may emerge as the largest product liability cases of this decade.

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As a Dangerous and Defective Drug attorney, I am writing this opinion piece, regarding the latest US Supreme Court Generic Drug Decision, which in my humble opinion is disastrous to Patient Safety. The case is PLIVA, Inc. v. Mensing.


On June 23, 2011, the United States Supreme Court ruled in a 5-4 decision that Generic Drug Manufacturers cannot be sued for failing to warn consumers of the possible side effects of their defective products, as long as they use the same warnings on the brand-name drugs. This decision is absurd on its face; this means that brand-name drug manufacturers can be held responsible for their failure to warn consumers about the dangers, but generic manufacturers are now provided an all encompassing shield that brand-name manufacturers do not have.

The seriousness and ramifications of this opinion cannot be understated. The Court’s decision now prevents millions of Americans, who have been seriously injured by generic drugs, from seeking compensation for their injuries. Generic drug manufacturers have a huge business in the United States. This opinion immunizes those drug manufacturers from liability. Another win for Big Pharma, and the consumer gets it again.

As a Crestor Side Effect attorney and cardiologist, I am writing this blog article to highlight the side effects of cardiac for patients who are taking statins, particularly Crestor to manage their high cholesterol levels.


According to new medical studies, the use of statins, especially Crestor, can be a major cause of cardiomyopathy, a heart problem caused by heart muscle weakening. Statins are prescribed to lower cholesterol levels. The drugs do this by by inhibiting the key enzyme HMG-CoA reductase, which is involved in the cholesterol synthesis pathway. But a side effect of statins leads to reduced levels of Coenzyme Q10, an important chemical required for proper muscle functioning.

A 2009 Lancet article focused on that issue and indicated that statins, like Crestor, as one cause of heart failure. (See Florkowski, S Molyneux, P George, M Lever, N-3 polyunsaturated fatty acids and statins in heart failure, Lancet 2009.)
Cardiovascular side effects from Crestor use are serious and may be life-threatening. If you or a loved one experienced cardiovascular injury or death, congestive heart failure, or immune-mediated necrotizing myopathy while taking Crestor, you may have a claim.

Crestor (generically known as Rosuvastatin), is an oral prescription drug designed to reduce the cholesterol blood levels when used together with lifestyle changes of diet and exercise. AstraZeneca, the manufacturer, designed the drug to reduce the production of cholesterol in the liver and by increasing the liver’s ability to remove “bad” LDL cholesterol. Crestor has been marketed as a “super-statin” because it claims to lower LDL cholesterol more than other statin drugs.

There are currently five statin drugs on the market in addition to Crestor: Lescol (fluvastatin), Lipitor (atorvastatin), Mevacor (lovastatin), Pravachol (pravastatin) and Zocor (simvastatin). Baycol (cerivastatin), another statin drug, was removed from the market in 2001 because of serious side effects reported by patients.

Crestor History

The FDA withheld approval for Crestor following concerns to the recall of Baycol and the kidney and muscle side effects reported in Crestor drug trials that were similar to those associated with Baycol. The FDA approved Crestor in August 2003 for the 5, 10, 20, and 40 mg doses following a clinical trial involving approximately 12,000 patients. The 80 mg dosage was not approved.

In March 2004, the non-profit organization Public Citizen asked the FDA to remove Crestor from the market, stating that Crestor side effects were severe and that the drug should never have been placed on the market. Read the FDA response to the Public Citizen petition on Crestor. The FDA issued a Public Health Advisory for Crestor on June 9, 2004, warning of the “increased risk for serious muscle toxicity (myopathy) associated with Crestor use, especially at the highest approved dose of 40 mg.”
In March 2005, the FDA issued an alert warning that “Rhabdomyolysis (serious muscle damage) has been reported in patients taking Crestor as well as other statin drugs. The labeling for Crestor has been revised to include information on the safe use of Crestor to reduce the risk for serious muscle toxicity, especially at the highest approved dose of 40 mg.”
Zocor Side Effects and Warnings

FDA in June 2011 warned about the risk of muscle injury in patients taking the highest dose of anti-cholesterol Zocor. Now patients and plaintiffs considering a Crestor lawsuit may be considering if the FDA’s Zocor warning applies to Crestor side effects. The FDA has recommended to patients and doctors that, “Zocor, Simvastatin 80 mg should not be started in new patients, including patients already taking lower doses of the drug.”

SEARCH Study Results Leads to FDA Zocor Warning

The recent FDA study was based on data from the trial SEARCH (Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine) which assessed the frequency of serious cardiovascular injuries, including heart attack and death, in patients who took the maximum Zocor dosage of 80 mg as compared to those who took only 20 mg of the drug.

Crestor Side Effects Similar to Zocor Warning

Zocor muscle injuries are similar to the Crestor side effects. The higher the dosage of a “super-statin,” the greater the risk a patient runs of developing Crestor side effects such as muscle pain and weakness, and the potentially fatal rhabdomyolysis, in which muscle fiber breakdown products is released into the bloodstream and causes kidney damage or failure.

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Dr Shezad Malik Law Firm is currently evaluating and accepting Fosamax long bone fracture cases and defective drug product liability claims. We are providing this Fosamax lawsuit update for the benefit of our readers and current Fosamax injury clients.


All federal Fosamax Femur low-impact bone fractures lawsuits have been consolidated for pretrial proceedings as part of a new MDL, or multidistrict litigation, which will be centralized in the U.S. District Court for the District of New Jersey.

At least 37 Fosamax fracture lawsuits are currently pending in federal district courts throughout the United States, and those cases will be transferred to New Jersey for further litigation. In addition, as new complaints over femur fractures on Fosamax are filed in the federal court system, they will also be added to this new MDL.

Fosamax lawsuits over jaw problems, known as osteonecrosis of the jaw, which will remain centralized as part of a different MDL in the U.S. District Court for the Southern District of New York.

All of the complaints involve similar allegations that side effects of Fosamax, can increase the risk of atypical thigh bone fractures, which often occur with little or no trauma at all. Plaintiffs claim that Merck failed to adequately warn about the risk of femur fractures from Fosamax, or that users should seek immediate medical attention if they experience groin pain, which may occur several weeks before a complete fracture while on Fosamax.

In October 2010, the FDA required new warnings about the risk of bone fractures from Fosamax and other similar bisphosphonate medications. There are currently more than 900 Fosamax jaw lawsuits consolidated in New York, as part of an MDL that was established in August 2006. Fosamax fracture lawsuits were previously excluded from that MDL, because it was determined that the evidence of general causation leading to femur fractures would likely differ substantially from cases dealing with jaw bone damage.

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As a DePuy Pinnacle Hip Failure and Replacement Attorney, I am providing this new information for my product liability clients.


On August 2010, there was a recall of the DePuy ASR XL artificial hip, and now DePuy may be facing the recall of the Pinnacle Acetabular Component. All federal lawsuits over DePuy Pinnacle hip replacement problems have been consolidated for pretrial proceedings as part of an MDL, or multidistrict litigation, which will be centralized in the U.S. District Court for the Northern District of Texas, Dallas.

The U.S. Judicial Panel on Multidistrict Litigation issued an order establishing the MDL, which will result in the transfer of 60 DePuy Pinnacle hip lawsuits currently pending in federal district courts throughout the United States.

Like the DePuy ASR XL, the Depuy Pinnacle is a metal on metal system that was designed to last at least 10-15 years but now, orthopedic surgeons are reporting that these devices have been failing within one to two years of being implanted into their patients.

DePuy, a division of Johnson & Johnson, has implanted over 150,000 Pinnacle hip replacements since 2001. Its recent recall of the defective ASR metal-on-metal hip implant systems has thousands of hip implant patients to have additional hip revision surgeries.

The ASR and Pinnacle are both metal on metal systems, and the ASR is a monoblock design, the Pinnacle uses a modular system. The ASR cup is made of one solid piece of metal, the Pinnacle has an outer shell and the Pinnacle is designed allow the surgeon the option to place a metal, ceramic or polyethylene liner inside the metal outer cup.

The Pinnacle 36 mm Ultamet Metal-on-Metal component is failing at an unacceptably high rate. Research suggests that there is a design problem, and the device has been created with one of the lowest clearance levels in the industry. Experts investigating the product design believe that DePuy created a very narrow window for proper placement of the prosthesis and inadequately trained surgeons in the proper implantation technique.

The recalled DePuy ASR system and the Pinnacle was permitted under the U.S. Food and Drug Administration’s (FDA) 510(k) approval process, which allows a medical device to be placed on the market without being subjected to clinical trials as long as the manufacturer can show that the device is “substantially equivalent” to a device already approved on the market. DePuy’s ASR system avoided clinical trials by showing that it was similar to the DePuy Pinnacle hip replacement system.

The FDA has received complaints and adverse incident reports against the Pinnacle system, and the Pinnacle’s propensity to prematurely separate from the bone. Constant friction in the metal on metal Pinnacle causes an increased risk of metallosis, the release of metal particles into the surrounding soft tissue or bloodstream, particularly chromium and cobalt.

The Dr Shezad Malik Law Firm hip replacement team continues to investigate claims of Pinnacle failures and counsel our clients on what to do in the event that they need revision surgery.

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